BUFFALO, N.Y. — Roswell Park Cancer Institute (RPCI) has received U.S. Food and Drug Administration (FDA) approval to enroll patients in a phase II clinical trial that will use a unique and highly precise method of delivering interstitial photodynamic therapy (I-PDT) to recurrent tumors of the head and neck.

Most patients with recurrent and nonresectable head-and-neck cancer experience poor quality of life and a projected survival that is measured in months. I-PDT is an additional treatment option that may improve outcomes for patients who respond poorly to standard therapies.

“These patients have no effective treatment options,” says Gal Shafirstein, DSc, principal investigator of the study and a member of RPCI’s Departments of Cell Stress Biology and Head & Neck/Plastic & Reconstructive Surgery. “We hope to learn through this study whether we can improve their overall survival by adding interstitial photodynamic therapy to standard treatment approaches.”

PDT, a treatment approach developed at RPCI, uses laser light to activate a nontoxic drug called a photosensitizer. The process works in three ways: it destroys cancer, shuts down blood vessels that “feed” the tumor, and prompts the immune system to kill cancer cells throughout the body. It is associated with mild side effects and can be combined with standard chemotherapy and surgery, and followed with radiation therapy.

Initiated by Dr. Shafirstein, the phase II clinical trial will use the photosensitizer Photofrin®, manufactured by Pinnacle Biologics, Inc., which is funding the trial. The study will be conducted in collaboration with Thomas Foster, PhD, and Timothy Baran, PhD, both of the Department of Imaging Sciences at the University of Rochester Medical Center.

Treating physician Hassan Arshad, MD, a surgical oncologist in RPCI’s Department of Head & Neck/Plastic & Reconstructive Surgery, will be responsible for all clinical aspects of the study.

The clinical trial will borrow treatment-delivery techniques already used in the field of radiation medicine. Advanced treatment planning developed specifically for I-PDT will help the team to calculate the precise dose of laser light needed for each section of a tumor. That information will be used to treat tumors while minimizing damage to healthy tissue.

Patients enrolled in the study will undergo pretreatment imaging with computed tomography (CT). A three-dimensional image of the tumor will then be created with CT scans to determine the number and correct placement of the optical fibers that will deliver the laser light. The patients will receive Photofrin, followed by a two-day waiting period to allow the photosensitizer to be absorbed by the cancer cells. The treatment will be conducted while the patient is under general anesthesia. The optical fibers will be inserted through the skin and into the tumor at specific, predetermined points. A light-dosimetry system developed by Dr. Shafirstein in his RPCI lab will measure, in real time, the light being delivered by each optic fiber, giving the medical team the information needed to make necessary adjustments to meet the goals of the treatment plan.

“Collaborating with Roswell Park is an important step in expanding our clinical development platform for PDT with Photofrin,” says Mark Thompson, chief executive officer of Concordia Healthcare Corp., parent company of Pinnacle Biologics. “Increased education, awareness and use of the dosimetry device, and the statistically significant outcomes we have achieved in other rare and hard-to-treat cancers, will inform this process and will, we hope, lead to better and more options for critically ill patients.”

“We hope that these state-of-the-art approaches will maximize the potential benefit of this therapy for patients with recurrent head and neck tumors,” Dr. Shafirstein adds.

Photodynamic therapy with Photofrin® is a two-stage process requiring administration of both drug and light. The first stage of PDT is the intravenous injection of Photofrin. The second stage of therapy uses illumination with non-burning laser light 24–50 hours following injection with Photofrin®. When injected, Photofrin® is attracted to certain tissues, especially cancer cells. Tumor destruction results from biochemical reactions, not heat. Tumor selectivity occurs through a combination of preferential retention of Photofrin® by the tumor and selective delivery of light to the tumor site. Photofrin® is FDA-approved for the treatment of non-small cell lung cancer (NSCLC) and esophageal cancer. The product is available in the USA, several major European countries, Japan, several Latin American and Southeast Asian markets. Photofrin® also is approved for high-grade dysplasia (HGD) in Barrett’s esophagus (BE) in North America. It also has Orphan Drug Designation (ODD) for cholangiocarcinoma and as adjuvant therapy to surgery for the treatment of malignant pleural mesothelioma. For additional information about Photofrin®, please see full prescribing information available at www.photofrin.com.

About Pinnacle

Pinnacle Biologics, Inc., a U.S.-based subsidiary of Concordia Healthcare Corp., is a biopharmaceutical research and development company specializing in orphan diseases. The company is headquartered in Bannockburn (suburban Chicago), Illinois. Its European subsidiary, Pinnacle Biologics BV, is headquartered in Amsterdam and is the holder of the European Marketing Authorizations for Pinnacle products.

About Roswell Park Cancer Institute

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci@roswellpark.org. Follow Roswell Park on Facebook and Twitter.